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BIIB057 in Subjects With Rheumatoid Arthritis and Inadequate Response to Disease-Modifying Antirheumatic Drugs (EMBRACE)

Primary Purpose

Rheumatoid Arthritis

Status
Withdrawn
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
BIIB057
Placebo
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, DMARD-IR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult onset RA satisfying 2010 Revised ACR Criteria for the Classification of RA with a disease history of at least 6 months
  • Active RA as defined by: at least 4 swollen joints (based on 28-joint count), at least 4 tender joints (based on 28-joint count), and high-sensitivity CRP (hsCRP) 10mg/L or greater
  • No prior treatment with biologics
  • Receiving a DMARD therapy for at least 3 months, using a regimen that has been stable for at least 28 days prior to screening

Exclusion Criteria:

  • History of inflammatory joint disease other than RA
  • Abnormal chest X-ray consistent with tuberculosis, malignancy, or infection
  • History of malignancy, carcinoma in situ, or high-grade dysplasia
  • History of opportunistic infection, infection requiring treatment, serious local infection, recent fever, active herpes zoster or Epstein-Barr virus, or diagnosis or family history of Creutzfeldt-Jakob disease.
  • Clinically significant cardiac disease
  • Treatment with prednisone >10 mg orally daily
  • Intra-articular steroid injection within 28 days before screening
  • Clinically significant abnormality in hematology or blood chemistry values at screening

Sites / Locations

  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo + Background Therapy

BIIB057 Dose 1 + Background Therapy

BIIB057 Dose 2 + Background Therapy

BIIB057 Dose 3 + Background Therapy

Arm Description

Background therapy including DMARD(s) approved by protocol

Background therapy including DMARD(s) approved by protocol

Background therapy including DMARD(s) approved by protocol

Background therapy including DMARD(s) approved by protocol

Outcomes

Primary Outcome Measures

Proportion of subjects achieving an ACR20 response (ACR20 = American College of Rheumatology 20% response criteria change from baseline)

Secondary Outcome Measures

Assess the safety and tolerability of BIIB057 by measuring the incidence of AEs, SAEs and changes in laboratory test results during the study
Proportion of subjects with 28-joint count Disease Activity Score with C-reactive protein (DAS28-CRP) <3.2, <2.6, and <2.32
Proportion of subjects achieving ACR50 and ACR70 response

Full Information

First Posted
July 19, 2012
Last Updated
September 12, 2013
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT01652937
Brief Title
BIIB057 in Subjects With Rheumatoid Arthritis and Inadequate Response to Disease-Modifying Antirheumatic Drugs
Acronym
EMBRACE
Official Title
A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of BIIB057 in Subjects With Rheumatoid Arthritis Who Have Had an Inadequate Response to Disease-Modifying Antirheumatic Drugs
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Withdrawn
Study Start Date
August 2012 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Phase II study designed to evaluate the safety and efficacy of BIIB057 in Subjects with Rheumatoid Arthritis who have experienced an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, DMARD-IR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo + Background Therapy
Arm Type
Placebo Comparator
Arm Description
Background therapy including DMARD(s) approved by protocol
Arm Title
BIIB057 Dose 1 + Background Therapy
Arm Type
Experimental
Arm Description
Background therapy including DMARD(s) approved by protocol
Arm Title
BIIB057 Dose 2 + Background Therapy
Arm Type
Experimental
Arm Description
Background therapy including DMARD(s) approved by protocol
Arm Title
BIIB057 Dose 3 + Background Therapy
Arm Type
Experimental
Arm Description
Background therapy including DMARD(s) approved by protocol
Intervention Type
Drug
Intervention Name(s)
BIIB057
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral
Primary Outcome Measure Information:
Title
Proportion of subjects achieving an ACR20 response (ACR20 = American College of Rheumatology 20% response criteria change from baseline)
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Assess the safety and tolerability of BIIB057 by measuring the incidence of AEs, SAEs and changes in laboratory test results during the study
Time Frame
Up to 16 weeks
Title
Proportion of subjects with 28-joint count Disease Activity Score with C-reactive protein (DAS28-CRP) <3.2, <2.6, and <2.32
Time Frame
Week 12
Title
Proportion of subjects achieving ACR50 and ACR70 response
Time Frame
Week 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult onset RA satisfying 2010 Revised ACR Criteria for the Classification of RA with a disease history of at least 6 months Active RA as defined by: at least 4 swollen joints (based on 28-joint count), at least 4 tender joints (based on 28-joint count), and high-sensitivity CRP (hsCRP) 10mg/L or greater No prior treatment with biologics Receiving a DMARD therapy for at least 3 months, using a regimen that has been stable for at least 28 days prior to screening Exclusion Criteria: History of inflammatory joint disease other than RA Abnormal chest X-ray consistent with tuberculosis, malignancy, or infection History of malignancy, carcinoma in situ, or high-grade dysplasia History of opportunistic infection, infection requiring treatment, serious local infection, recent fever, active herpes zoster or Epstein-Barr virus, or diagnosis or family history of Creutzfeldt-Jakob disease. Clinically significant cardiac disease Treatment with prednisone >10 mg orally daily Intra-articular steroid injection within 28 days before screening Clinically significant abnormality in hematology or blood chemistry values at screening
Facility Information:
Facility Name
Research Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 3J5
Country
Canada
Facility Name
Research Site
City
Quispamsis
State/Province
New Brunswick
ZIP/Postal Code
E2E 4J8
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

BIIB057 in Subjects With Rheumatoid Arthritis and Inadequate Response to Disease-Modifying Antirheumatic Drugs

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